Bone and joint infection

Bone and joint infections are most often caused by a type of bacteria known as Staphylococcus (or Staph for short). Staph infections are usually treated with antibiotics, often for several weeks, depending on the exact type of infection. Some Staph bacteria can become resistant to these antibiotics, which means that they can no longer be killed by that antibiotic. Also, the commonly used antibiotics do not kill only Staph bacteria but they kill other bacteria, including the beneficial bacteria normally present in your body.

Clinical trials

A ‘clinical trial’ is a research study in which people agree to test a new treatment to prevent or improve a disease or medical condition. A clinical trial also looks at how participants react to the new treatment and if any unwanted effects occur. This helps to determine if the new treatment works, is safe, and is better than those that are already available. Many clinical trials also compare existing treatments or test new ways to use or combine existing treatments.

A.

Clinical Trial of Afabicin in Bone or Joint Infections due to Staphylococcus

In this study, a new antibiotic is tested as a potential treatment for Staph specific infections that no longer respond to other antibiotics. This antibiotic is called afabicin
Definition
afabicin (Debio 1450) is a first-in-class new antibiotic benefiting from both oral and intravenous (IV) formulations. It is a highly potent, Staphylococcus-selective antibiotic with a low propensity to develop resistance. This FabI inhibitor is also active against staphylococci strains which are resistant to the current standard-of-care antibiotics such as beta- lactams, vancomycin, daptomycin or linezolid. Debio 1450, perfectly suited to tackle several hard-to-treat infections, is now studied in Bone & Joint infections (BJIs) caused by staphylococci. More info
. It is developed by Debiopharm International S.A (also called Sponsor). Afabicin has been designed to kill only Staph and not other bacteria.

Patients with the following indications will be included in the proposed study: Septic arthritis (including acute and chronic forms) or Osteomyelitis (including vertebral and long bone osteomyelitis whether hematogenous, contiguous, or associated with trauma).

The primary objective of this study is to determine the safety and tolerability of afabicin
Definition
afabicin (Debio 1450) is a first-in-class new antibiotic benefiting from both oral and intravenous (IV) formulations. It is a highly potent, Staphylococcus-selective antibiotic with a low propensity to develop resistance. This FabI inhibitor is also active against staphylococci strains which are resistant to the current standard-of-care antibiotics such as beta- lactams, vancomycin, daptomycin or linezolid. Debio 1450, perfectly suited to tackle several hard-to-treat infections, is now studied in Bone & Joint infections (BJIs) caused by staphylococci. More info
.

Patients will be treated either with afabicin
Definition
afabicin (Debio 1450) is a first-in-class new antibiotic benefiting from both oral and intravenous (IV) formulations. It is a highly potent, Staphylococcus-selective antibiotic with a low propensity to develop resistance. This FabI inhibitor is also active against staphylococci strains which are resistant to the current standard-of-care antibiotics such as beta- lactams, vancomycin, daptomycin or linezolid. Debio 1450, perfectly suited to tackle several hard-to-treat infections, is now studied in Bone & Joint infections (BJIs) caused by staphylococci. More info
, or with the comparator, meaning the standard antibiotic therapy which is currently recommended to treat staphylococcus infections. The comparator will be selected by the study doctor among the following: cefazolin, clindamycin, linezolid or vancomycin for the infusion treatment, and linezolid or clindamycin for the oral treatment.

Patients will be treated with infusion of afabicin
Definition
afabicin (Debio 1450) is a first-in-class new antibiotic benefiting from both oral and intravenous (IV) formulations. It is a highly potent, Staphylococcus-selective antibiotic with a low propensity to develop resistance. This FabI inhibitor is also active against staphylococci strains which are resistant to the current standard-of-care antibiotics such as beta- lactams, vancomycin, daptomycin or linezolid. Debio 1450, perfectly suited to tackle several hard-to-treat infections, is now studied in Bone & Joint infections (BJIs) caused by staphylococci. More info
160 mg BID (2 doses) for a minimum of 1 day and up to a maximum of 14 days (2 weeks), followed by a switch to oral afabicin
Definition
afabicin (Debio 1450) is a first-in-class new antibiotic benefiting from both oral and intravenous (IV) formulations. It is a highly potent, Staphylococcus-selective antibiotic with a low propensity to develop resistance. This FabI inhibitor is also active against staphylococci strains which are resistant to the current standard-of-care antibiotics such as beta- lactams, vancomycin, daptomycin or linezolid. Debio 1450, perfectly suited to tackle several hard-to-treat infections, is now studied in Bone & Joint infections (BJIs) caused by staphylococci. More info
at a dose of 240 mg BID (2 doses) for the remaining treatment duration

Depending of the indication, patients will be recruited in 3 cohorts: In cohort 1 (notably Septic arthritis) patients will be treated with afabicin
Definition
afabicin (Debio 1450) is a first-in-class new antibiotic benefiting from both oral and intravenous (IV) formulations. It is a highly potent, Staphylococcus-selective antibiotic with a low propensity to develop resistance. This FabI inhibitor is also active against staphylococci strains which are resistant to the current standard-of-care antibiotics such as beta- lactams, vancomycin, daptomycin or linezolid. Debio 1450, perfectly suited to tackle several hard-to-treat infections, is now studied in Bone & Joint infections (BJIs) caused by staphylococci. More info
for a maximum of 3 weeks. In cohort 2 for a maximum of 6 weeks and in cohort 3 (notably Osteomyelitis) for a maximum of 12 weeks. After the end of treatment, patients will be followed up for 12 weeks.

Phases

When a potential new medication is being developed, it is first tested in a laboratory setting. If the results are positive, the drug may enter a clinical trial program. This means that it will be tested in humans in several ‘phases’ of study.

Phase I = Safety evaluation. The very first administration in humans, typically carried out in a small group of healthy volunteers to assess if the drug is safe.
Phase II = Efficacy evaluation. The first trials in patients with the intended disease to check if the drug works efficiently and if there are any unwanted side effects.
Phase III = Confirming findings. Trials in large numbers of patients that generally compare the drug to the best treatments available.

Talk with your medical doctor

If you are interested in participating in an upcoming clinical trial, ask your doctor if a clinical trial might be right for you. Your doctor knows both you and your health history, which is invaluable in making this decision. Your doctor can help you gather the information needed to locate a trial and help you identify what questions might be important to ask before deciding to participate. When you join a clinical trial, you will still receive care from your primary doctor for your overall health. Most trials are only for a limited time and only pertain to the condition being studied.